Gap Assessment For Laboratory Development CMLS - SL (BOOK 1)

State sector healthcare services of
Sri Lanka provide universal health

care delivery to the nation. State
sector Medical Laboratory Service is
a part of health care delivery which
provides services mainly in curative
care. As per the transformation of
disease trend from communicable
disease to non-communicable
diseases laboratory service is being
expanded towards primary
healthcare service aiming prevention
and control of non-communicable
diseases (NCD). Primary healthcare
strengthening project works towards
non communicable disease control in Sri
Lanka.
Strengthening
Medical Laboratory Service
in Sri Lanka
College of Medical Laboratory Science

Sri Lanka
Table of Contents
Strengthening Medial Laboratory Service in Sri Lanka ........................................... 2
1.1 Background: ........................................................................................................ 2
1.2 Function of Medical Laboratories ........................................................................ 4
1.3 Objectives ........................................................................................................... 6
Process ............................................................................................................................ 6
2.1. Laboratory Organization and Structure: ............................................................. 6
2.2 Human Resource ................................................................................................. 7
2.3 Point of Care Testing for NCD screening program ............................................... 9
2.4 Laboratory Information Management System (LIMS) ......................................... 9
2.5 Total Quality Management ............................................................................... 10
3.0 Special Remarks of Assessment ........................................................................... 10
3.1 Sri Lanka Accreditation Board (SLAB) ................................................................ 10
3.2 Training Needs .................................................................................................. 11
Attachments
Quality Management in Primary Medical Care Units ............................................ 12
Selection of POCT devices for Primary Healthcare Strengthening Project ......... 15
Proposal for Developing LIMS .................................................................................. 18
LIMS) for Apex Base Hospitals with Satellite Clinics in the Peripheral Areas .... 21
CMLS.SL Address: No. 25/2, Norris Avenue, Colombo 08, Sri Lanka 1
Web: www.cmlssl.org / email: cmlssrilanka@gmail.com
1.0 Strengthening Medial Laboratory Service in Sri Lanka
State sector healthcare services of Sri Lanka provide universal health care delivery to the nation.
State sector Medical Laboratory Service is a part of health care delivery which provides services
mainly in curative care. As per the transformation of disease trend from communicable disease to
non-communicable diseases laboratory service is being expanded towards primary healthcare service
aiming prevention and control of non-communicable diseases (NCD). Primary healthcare
strengthening project works towards non communicable disease control in Sri Lanka.
1.1 Background:
Medical laboratory service playas a major role in NCD screening and PSSP develops peripheral
laboratory set up focusing level 2 and below levels of hospitals and primary medical care units
(PMCU). This document provides proposal to empower the laboratory professionals for maximum
utility of laboratory service facilitating general public in NCD control.
Healthcare institutions have been classified as Apex institutions and Primary care institutions. Apex
institutions include National Hospital, Teaching hospitals and Provincial General Hospitals; district
General Hospitals (tertiary hospitals) which cater for curative care basically. All tertiary institutions
are under central government. Secondary hospitals (Base hospitals A and B) of apex institutions cater
mostly for curative care less for preventive care. Most of the institutions are under provincial
councils.
Primary health care institutions have been classified as Level 1 and Level 2. Level 1 consists of
primary medical care units and Level 2 consists of divisional hospitals (A, B and C). These are
basically providing services in primary care facilitating preventive care delivery. All primary care
institutions are under provincial councils.
When it comes to the laboratory service of this set up, Tertiary institution laboratories are with
clinical laboratory consultants, medical laboratory scientists and medical laboratory technologists.
Secondary institution laboratories consist of medical laboratory scientists, medical laboratory
technologists and clinical laboratory consultants in some places.
Level 2 hospital laboratories are with medial laboratory scientists and medical laboratory
technologists. Some level 2 hospital laboratories are run with one laboratory practitioner while some
level 2 laboratories are run with two or more laboratory practitioners. Some level 2 hospital
laboratories do not have any laboratory practitioner.
Level 1 institutions are lack of any laboratory professional or laboratory set up. Primary care system
strengthening project expects to develop a laboratory screening process with level 1 and level 2
institutions. Further it is planned to develop laboratory set up in level 2 institutions while developing
point of care testing (POCT) facilities for NCD screening in level 1 institutions.
HOSPITALS
Primary Secondary Tertiary
Level 2 Level 1 Base Base National Teaching Provincial District

Hospital A Hospital B Hospital Hospitals General General
Hospitals Hospital
s
Divisional Primary Medical

Hospitals A Care Units
Divisional
Hospitals B
Divisional
Hospitals C
Figure 1: Hospital laboratory set up in Sri Lanka
1.2 Function of Medical Laboratories
According to above classification laboratory facilities and functions of the laboratory can be
formulated.
1.2.1 Tertiary care Laboratories:
These laboratories are apex institutions. A Tertiary care hospital laboratory function with highest
range of laboratory tests including specialized laboratory investigations with fully automated
laboratory equipment. Some tertiary care hospitals act as regional referral laboratory. These
laboratories handle maximum number of specimens and highest number of laboratory practitioners
comparing other level of laboratories. Still most of tertiary care laboratories face problems with
manpower specially Medical Laboratory Scientists and Medical Laboratory Technologists.
Usually these laboratories participate with EQAS and TQM practices are available to a certain
extend. But any of these hospital laboratories have not been accredited with ISO 15189. Further still
all these laboratories are with huge gap with accreditation requirements. Different laboratories are
having different level of TQM practices varying in Quality aspects.
These laboratories are clinically managed under a clinical laboratory consultant with superintendent
Medical Laboratory Technologist, Chief Medical Laboratory Technologist and Laboratory
practitioners including Medical Laboratory Scientists and Medical Laboratory Technologists as
Laboratory practitioners.
Equipment and suppliers are under the supervision of Superintendent Medical Laboratory
Technologist and chief Medical Laboratory Technologists in each Discipline (Clinical Biochemistry,
Hematology, Histopathology and Microbiology) with the observation of clinical Laboratory
Consultants. Outpatient Department Laboratories are functioned in tertiary care Hospitals with Chief
Medical Laboratory Technologist and other laboratory practitioners following same practice as other
laboratories.
Infection control and Biosafety measures are practiced as Bio-risk management in different levels
and many gaps could be identified in different laboratories. Some infra-structural, supplies and
financial deficiencies may course these gaps and there are no specified laboratory set up or dedicated
laboratory scientist for Bio-risk Management specially in laboratory set up (Eg: Needle prick injury
management and risk assessing laboratory facilities at the same hospital)
Laboratory Information Management has not yet been implemented successfully in any hospital in
Sri Lanka. There is no properly integrated system with HIMS and there are some instrument linked
in-house information transferring system in some laboratories which do not fulfill the expete
outcome of LIMS.
1.2.2 Secondary care laboratories:
These laboratories are functioned in different level considering test range, human resources,
laboratory equipment and facilities, TQM aspects and work load. Maximum variation on these
aspects could be seen in this laboratory level. Some institutions may have clinical laboratory
consultants. Laboratory is run with Chief Medical Laboratory Technologist, Medical Laboratory
Scientists and Medical Laboratory Technologists. These laboratories have gaps with ISO 15189
standards, infra structural deficiencies, lack of fully automated analyzers in some places, manpower
deficiencies especially in Medical Laboratory Scientists and Medical Laboratory Technologists and
lack of TQM practices including quality assurance can be noticed at this laboratory level in wide
range of variations among different laboratories. Equipment and supplies are carried out by chief
medical laboratory technologist through institutional head. , bio- risk management, are carried out
same way in tertiary level laboratory. LIMS have not been implemented in these hospitals and its
status is same as in tertiary level laboratories.
This huge variation in facilities and functions of laboratory should be highly concerned in developing
these laboratories with different phases which are suited with different laboratories considering their
existing status.
1.2.3 Primary care laboratories:
Laboratory facilities are available differently in level 2 hospital laboratories. Mostly basic laboratory
investigations are carried out by one or more medical laboratory practitioners. There are no clinical
consultants and only Medical Laboratory Scientists or/and Medical Laboratory Technologists are
available. They do equipment and sullies. There is no laboratory based proper Bio-risk management
process apart from basic universal precautions in infection control aspects. Most of laboratories are
with semi-automated analyzers and equipment. These laboratories are run with minimum practices of
TQM and quality assurance. Most of laboratories are underutilized with capacity to develop with
primary healthcare needs.
1.3 Objectives
It is expected to achieve following objectives in primary healthcare system strengthening project

ensuring quality and sustainable primary healthcare laboratory service in Sri Lanka.
1. Improve primary healthcare laboratory setting with Human resource, TQM practices and
LIMS
2. Improve primary healthcare POCT process in NCD screening program
2.0 Process
Above objectives will be achieved by systemizing laboratory management system and POCT process
as follows. As per the above description level 2 institution laboratories are run with minimum
facilities and poor systematic management process ensure the quality and laboratory standards due to
lack of clinical laboratory consultants and scientists with close monitoring system. These level 2
laboratories and apex laboratories (Secondary hospital Laboratories) can be developed toward the
requirement of PSSP. It is focused following aspects in order to develop these laboratories.
2.1. Laboratory Organization and Structure:

It is expected to develop Point of Care Testing process n primary medical care units (PMCU) where
medical laboratory set up or medical laboratory practitioners are not available. These POCT devices
will be handled by non-laboratory professionals and which are used for ruling in and ruling out
purposes in screening program. It is planned to monitor the process under supervision of medical
laboratory scientist through a quality management program which is described in later part of this
document. Level 2 laboratories can be developed with facilities for primary care delivery. It has huge
capacity to develop and it is expected to expend up to secondary lab investigations.
Some times when referrals of primary care comes to the curative laboratory set up it can be neglected
or deprioritized due to less relevance to curative laboratory objectives. Therefore it is suggested to
establish primary care referral laboratory in each district following the existing referral system in
curative care. It is suggested to develop this laboratory in base hospitals of each district based on
geographical and population basis. If there is no base hospital (secondary hospitals) with population
or geographical basis it is suggested to develop a suitable divisional hospital (Level 2) as the regional
referral lab of that region.
These primary care referral laboratories will be facilitated with most of tertiary level lab
investigations related to the primary care health needs with separate human resources including
Medical Laboratory Scientists and Medical Laboratory Technologists. These referral laboratories
should be geographically distributed.
Highly advanced investigations will be referred to tertiary hospital laboratories as it is not cost
effective to establish highly specialized test in regional referral laboratories. Later a national referral
laboratory for primary are can be developed in order to handle primary care system independently
from curative care system.
These regional referral laboratories are developed with ISO 15189 standards and coordinates with
lower level TQM process and coordination with higher authorities with regard to the TQM in
primary care laboratory system.
2.2 Human Resource:
Human resources are required for different aspects in this development process. Primary healthcare
does not have cadre of Medical Laboratory Scientist or Medical Laboratory Technologists. Medical
Laboratory Scientist or Medical Laboratory Technologists cadre has been developed only for curative
service. Even though some divisional hospitals have Medical Laboratory Scientist or Medical
Laboratory Technologists who were appointed under curative care, these officers have not oriented
for primary re laboratory service. Therefore Medical Laboratory Scientist or Medical Laboratory
Technologists should be appointed for primary care laboratory needs. It is described as follows.
2.2.1 Medial Laboratory Scientists for Level 2 laboratories
Number of Medical Laboratory Scientist or Medical Laboratory Technologists required for

delivering primary health care laboratory service has not been surveyed and if the required number is
decided, it can be requested to increase the university intake accordingly in order to fulfill the
requirement of Medical Laboratory Scientists in primary healthcare system. Further schools of
Medical Laboratory Technology can utilize to train this requirement.
Further there are some barriers for cadre approval from ministry of finance without proper
justification and analysis for cadre increment even it is sent through ministry of health
recommendation. If this assessment can identify the required Medical Laboratory Scientist/ Medical
Laboratory Technologists cadre scientifically with a recommendation of World Bank in relation to
this project it will be a powerful input for cadre approval.
Further we have attached our proposal for laboratory development in PSSP and it explains that at the
stage 01 all divisional hospital laboratories are expected to fulfill with minimum of one Medical
Laboratory Scientist or Medical Laboratory Technologists and stage 2 it is expected to increase the
number of Medical Laboratory Scientist or Medical Laboratory Technologists for 2 in each level 2
laboratory and later the number will be increased assessing the process of the laboratory.
2.2.2 Divisional Medical Laboratory Technologists (24 officers)
Level 2 hospital laboratories are under the provincial councils. Proper coordination and regulation is
important in smooth function of the laboratories especially in quality management process of POCT,
equipment and supplies. It is suggested to appoint a divisional Medical Laboratory Technologist for
each district of the county to coordinate with provincial healthcare management. Further this officer
should be empowered by designating as divisional Medical Laboratory Technologist and giving a
separate list of duties and responsibilities.
2.2.3 Medical Laboratory Scientist for Quality Management
It is suggested to appoint Medical Laboratory Scientist for Quality Management from base hospital
which is the apex laboratory of the region or cluster setting up a proper monitoring system for
primary healthcare laboratory service. There are graduate medical laboratory scientists to ppoint for
this position. This officer coordinates with secondary institution and nominated laboratory consultant
of the Base hospital as an apex institution. Overall this officer coordinates the TQM process of the
cluster with upper level of the process and fulfillment of quality assurance requirements with the
nominated clinical laboratory consultant of the apex institution (Base hospital).This officer should be
able to monitor the laboratory and screening process of primary healthcare in quality management
aspects. This can be achieved by improving organizational structure and empowering dedicated
professionals in this process.
1. Create an dedicated position of medical laboratory scientist for Quality Management in each
apex laboratory (Base hospital laboratory)
2. Duties and responsibilities should be set up for these officers in relation to laboratory
management, supervision coordination with apex institutional clinical laboratory management
system.
3. Empower the dedicated officer with knowledge in laboratory science, quality and laboratory
management aspects while improving him on auditing and accreditation
2.3 Point of Care Testing for NCD screening program
Primary healthcare setting does not have an established screening program in Sri Lanka. Primary
healthcare system strengthening projects expects to establish and POCT set up in PMCU for NCD
screening purposes. They are planning to conduct Blood glucose, cholesterol, creatitnine and urine
albumin as POCT to the purpose of ruling in and ruling out at screening program . It is new to Sri
Lanka and planning to conduct a mass screening among population over 35 years old and other risk
groups. CMLS.SL believes the low cost POCT implementation is important in maximum utility of
funds towards population benefit and the screening process should include minimum steps without
laboratory related steps such as venous blood usage and centrifugation steps in pre analytical phase
because it is planned to conduct at PMCU where laboratory facilities or competent staff is not
available for additional laboratory related procedures. Further there should be well established
quality management system for POCT as there is no qualified laboratory professionals to handle
maintain this POCT equipment. Proposed POCT selection criteria of POCT equipment to ensure the
sustainability of POC testing process is described in Annexure 02.
2.4 Laboratory Information Management System (LIMS)

Sri Lanka does not have implemented LIMS in any hospital laboratory instead if linking of computer
based data entry with the instrument. LIMS has not been integrated with HIMS and still Sri Lanka
does not have properly functioned EMR. CMLS.SL suggests develop LIMS module with nationally
accepted specifications for the country and CMLS.SL have initiate to develop LIMS module for Sri
Lankan Medical Laboratory Service. It describes phases of developing LIMS and path to implement
a sustainable program. Annexure 3 describes the process of developing LIMS.
When it comes to POCT level it is not required to have complex information management system in
the device. It is sufficient to have data transferring system to computer software. Then computer data
can be organized in software and link with IMS according to the requirement. Further POCT devices
are handled by non- laboratory professionals and they do not have competency for handling LIMS. It
is noticed that these devices with LIMS are costly and introducing devices with LIMS to PMCU will
be unnecessary cost while limiting the choice of devices. Main focus should be gone to apex
laboratories and proposal has developed for the apex hospitals. CMLS.SL has developed a proposal
for LIMS focusing apex hospital laboratories (Annexure 4).
2.5 Total Quality Management
Proposed Quality Management system for the primary healthcare laboratory setting is given I
Annexure 01. It can be followed to supervise whole process of primary healthcare laboratory setting.
This process is supported with divisional Medical Laboratory Technologist.
At present Sri Lanka Accreditation Board (SLAB) is body which is responsible for medical
laboratory accreditation.
3.0 Special Remarks of Assessment
3.1 Sri Lanka Accreditation Board (SLAB)

There are consequences in SLAB involvement in accreditation process which were noticed in slow
moving of accreditation in Sri Lanka.
1. They have rejected the utilization of knowledge and professional relevance of medical
laboratory scientists in conducting accreditation process
2. They have restricted the assessor training only for the MBBS graduates who are having
clinical based degree while rejecting the graduate medical laboratory scientists who are
having professional BSc (honors) degree in medical laboratory Science which is the most
relevance degree for medical laboratory profession in Sri Lanka.
3. Even though there are qualified assessors with non MBBS degree have been ignored and their
service is refused.
4. Assessors in SLAB are not independent and they may attached to private institutions as
laboratory consultants and visiting professionals which may make biased in assessments.
5. Due to these reasons the accreditation process is not gone to the grass root level and its
credibility is very low.
6. SLAB accreditation process is not affordable for government institutions as these re non-
profit organizations with free health care delivery.
With this situation SLAB should be reorganized eliminating unreliable policies and standards which
badly affect medical laboratory quality development and laboratory accreditation process in Sri
Lanka.
Further state sector laboratories cannot achieve the accredited level simply and it is suggested to
uplift the laboratory quality step by step and each step should have close monitoring frequent
auditing and assessments. CMLS.SL suggests develop a team of assessors and auditors for medical
laboratory standardization in order to establish a sustainable quality development program and
accreditation in state sector institutions especially in primary care laboratory setting.
3.2 Training Needs

Following training needs have been identified in developing medical laboratory service of Sri Lanka.
1. Laboratory Assessor training for a team of medical laboratory scientists in ISO 15189, ISO
22870 order to audit laboratories for accreditation purposes. It is important for primary health
care laboratory quality improvement.
2. Post graduate study opportunities in specialties in laboratory science namely microbiology,

chemical pathology and haematology etc. It is important in serving places where clinical
laboratory consultants are not available and it improves the quality of decision making on
diagnostic results through analytical validation
3. Training for Chief Medical Laboratory Scientists or Chief Medical Laboratory Technologists
on TQM
Contributors:
Mr. Ravi Kumudesh – Collage of Medical Laboratory Science, Sri Lanka

Miss. Prabhani Pushpamalie – Collage of Medical Laboratory Science, Sri Lanka
Annexure 01
Quality Management in Primary Medical Care Units
Prepared by Level 2 Laboratory Development committee of primary health care strengthening

program (PSSP)
Primary medical care units will be facilitated with POCT in order to minimize turnaround time of
laboratory reports and it will be limited few tests namely urine albumin, plasma glucose level and
total cholesterol level. POCT reduces turnaround time of the laboratory reports through Simplified
process in following steps.
1. Simpler sample collection

2. Simpler pre-analytical processes
3. Rapidity of results
However, following disadvantages need to be noted in primary health care setting and precautions
should be taken to overcome or minimize the outcomes of these disadvantages.
1. Errors due to lack of expertise and insufficient quality control

2. Problems of comparability of results of different methods (laboratory versus non-laboratory)
3. Increased cost (equipment and reagents are expensive)
4. Cost of quality control high
5. Inadequate documentation of results
Total Quality Management of POCT
It is very important that POCT must be conducted within a framework of quality standards.
POCT is usually carried out by healthcare workers, who do not have formal training in quality
control and testing principles. Therefore, they do not have expertise to assess quality of results
produced by the POCT. Quality management of POCT is based on ISO 22870:2016.
The uses shall have

I. appropriate training and competency assessment
II. support network inclusive of standard operative procedures
III. access to training
IV. experts available for advice
Organizational Structure
Organizational structure should include following framework as in figure 01. Deputy Director
General (Laboratory Service) will be the focal point of this process. Program should be designed and
implemented under supervision of respective professional colleges namely College of chemical
pathologists, college of heamatologists, college of pathologists, college of microbiologists and
college of medical laboratory science. It is suggested to appoint a TQM Steering Committee
DDG (LS) / D (LS) / PDHSS

Representative from College of Chemical Pathologists, College of Hematologists, College of Histo
pathologists, College of Microbiologists, College of Medical Laboratory Science
Nominated Consultant Chemical Pathologist / Consultant Haematologist
Medical Laboratory Scientist (Divisional Quality Manager)
Divisional Medical Laboratory Scientist or Medical Laboratory Technologist
Other Medical Laboratory Scientist or Medical Laboratory Technologists
Healthcare workers performing POCT
Steps in Implementation and ongoing performance

I. Establishment of the need - type of POCT, tests needed
II. Evaluation & Validation
III. Preparation of SOP
IV. Training & competency evaluation
V. Implementation
VI. Quality control and calibrations
VII. Coordination and review of EQA programs
VIII. Periodic comparison with laboratory methods
IX. Provision of assistance
X. Record keeping
Quality Control
Internal quality control – number of samples tests shall be decided considering stability of POCT
device, type of test, frequency of testing, frequency of lot changing
External quality control – Depending on available finding and support of MRI can be obtained
Calibrations – need to be documented, Frequency given by manufacturer of device
Best method – periodic comparison with main laboratory.
Frequency – decided according to test type, number, type of POCT, technology
Range – close to medical decision levels, normal, high, low
Number of samples – to be decided
Annexure 02
Selection of POCT devices for Primary Healthcare Strengthening Project
Following important contents to be considered on the Primary healthcare Screening Programme and
purchasing POCT Devices
1. Accepted Parameters.
A. Considering the CKD screening at Primary healthcare level eGFR and ACR are
recommended parameter instead of the test by test measurement of Creatinine and Albumin.
Therefore we the CMLS.SL believe the devices which can provide eGFR and ACR
calculation directly is more effective than manual calculation of above parameters with test
by test measurement of Creatinine and Albumin
Screening Guidelines have explained screening tests which are used to diagnose Chronic Kidney
Disease. It explains two simple tests.
1. Urine Albumin Creatinine ratio (ACR) in spot urine specimen for albumin urea
2. Serum Creatinine to estimate glomerular filtration rate(eGFR)
It is given a guideline to refer a nephrologist for clinical management when eGFR < 30
mL/min/1.73m2 or ACR > 300 mg/g. (kidney.org accessed on 10.08.2019)
This guideline was supported by the screening guidelines for chronic kidney disease Sri Lanka
(2017). According to this guideline people with eGFR < 60 mL/min/1.73m2 or ACR > 300 mg/g
are considered as CKD screening positive. This document recommends obtain early morning
urine specimen for UACR detection.
B. Considering Diabetic Screening recommended and easiest screening parameter is Fasting

Capillary blood glucose (FCBS) and Random capillary blood glucose (RCBS). This method
is accepted as Global and National guideline for the screening of diabetes. Therefore when
purchasing the devices for diabetic screening it is more convenient to consider the devices
which can be used with FCBS and RCBS than Plasma glucose.
Diabetes Mellitus Management guidelines in Clinical Practice Guidelines of Ceylon College
of Physicians (2018) have explained the criteria for detection of diabetes mellitus as follows.
1. Capillary fasting plasma glucose

2. Post prandial capillary glucose
3. HbA1c
Report of a World Health organization and International Diabetes Federation meeting

(2003) has shown the reliability of using capillary blood glucose in detecting fasting,
random or post prandial glucose level.
2. The POC Screening is conducted outside the laboratory without Medial Laboratory Professionals
or medical laboratory set up. If we strictly consider serum or plasma test there should be
controlled pre analytical set up with venous blood collection and centrifugation process etc. It
will be an additional process consuming extra time, equipment. Such setup will create
unnecessary complexity of the process and it cannot be operated without a Medical Laboratory
Technologist.
Hence the Priority should be given to the devices which can provide accurate results with
capillary whole blood specimen. Further introducing capillary blood measurement will not
degrade the quality of the screening tests and there are many globally accepted devices that can
provide quality results with accuracy, precision and reliability which spends considerably low
cost.
Berke et al (2017) has explained the evaluation criteria of POCT. It has evaluated precision,
accuracy, comparison to gold standard method and ease of use as the parameters of POCT
evaluation.
3. This screening program is going to be established in large scale and it is important to provide
screening facility giving maximum utility of this program. Therefore cost is substantial in
selecting a device for POC screening. Cost per test and cost of device vary in huge range and
both should be minimized in order to maintain a sustainable screening program. If we spend huge
cost for the equipment or high cost per test, program will be end up with serving less number of
populations or program may last for short duration due to financial constraint. High end unusable
IT solutions, irrelevant integrated test profiles add unnecessary cost for the device and the test.
National Institute for health and care excellence (2018) has described different technologies and cost
comparison of POCT devices available with regulatory approval under European Union for blood
creatinine detection.
Considering the above mentioned factors which were proven with references and the exciting Sri
Lankan Primary healthcare Laboratory screening setup, the sustainability of the process can be
achieved by managing the process with capillary POCT devices apart from complex venous blood
devices. Therefore it is highly recommended to set up specification which can accommodate the
devices which are used in screening purposes without Medical Laboratory professionals and outside
of laboratory setup.
Annexure 3
Proposal for Developing a

Standard Laboratory Information Management System
Introduction
Sri Lanka has a rapidly expanding health care system. As a result of epidemiological, demographic
and socio-economic transition, Sri Lanka is currently experiencing triple burden of diseases
characterized by increasing prevalence of Non-Communicable diseases, higher incidence of injuries
and high incidence of certain communicable diseases. Therefore, the country is in need of
comprehensive health care that could reach up to the grass root level.
In provision of well-organized comprehensive preventive, curative and rehabilitative care, that could
address current and future needs of health care Sri Lanka requires more technologies and new
strategies. Hence the country is in the process of adopting new strategies such as strengthening of
primary health care system and introduction of new technologies.
The curative health service of the Sri Lanka’s Government sector is delivered through a network of
1118 hospitals operating in primary, secondary and tertiary levels. Although this network of
hospitals is supposed to provide comprehensive health service, they are less prepared for changing
burden of diseases and potential health emergencies. One of the specific challenges faced by the
government health sector in this regard is scarcity of quality laboratory services that cover all
diagnostic needs.
With the advancement of medical care with new technologies, health care providers largely depend
on laboratory investigations. Availability of vast range of laboratory investigations for all spectrums
of diseases, makes it easy for medical professionals to come in to timely and accurate diagnosis.
Hence, health system improvements cannot be achieved without a proper laboratory services and it
should be an integral part of all developments in the sector starting from the strategic levels.
Although the government health sector has facilities to provide laboratory services free of charge,
several deficiencies in the service drive people to seek lab service from the private sector. As a
result, major portion of Out of Pocket Expenditure (OOPE) on health service in Sri Lanka is
attributable to laboratory investigation. Furthermore, duplication of lab tests, erroneous reports,
delayed reports and un-necessary reports are common occurrences in the health sector.
The ability of the health system in provision of coordinated care across all levels largely depends on
improvement in existing health information system. A substantial difference could be made in health
care delivery, if the health information system would allow uniquely identifying patients, tracking
them over time, and sharing patient information across providers and databases. An electronic
medical information system would be the best intervention in this regard which in turn will improve
the quality of people- centered coordinated care.
In addressing the challenges of health care the government health sector has applied several
innovative approaches among which implementation electronic health information system (HIS) has
made promising progress over the past few years. The recent position paper developed by the
Ministry of Health (MoH) to reorganize and strengthen the Primary Health Care system, emphasizes
the necessity of expanded laboratory service capacity through Laboratory Information Management
System (LIMS).
Implementation of LIMS in the government’s health system would enhance the effectiveness and
cost effectiveness of laboratory service in the provision of people centered care from the grass root
level up to the highest level of care. LIMS prevents duplication of lab reports, errors in reports while
improving the timeliness, coordination and comprehensiveness of care.
PROPOSED PROGRAM FRAMWORK
Annexure 04
Design, Supply, Development, Implementation and Support for Laboratory

Information Management System (LIMS) for Apex Base Hospitals with Satellite
Clinics in the Peripheral Areas
Background and Justification:
In general an Apex Hospital is typically a Main Tertiary Hospital such as a Base Hospital is the
supporting the healthcare needs of large communities in localities around Sri Lanka. Hospital Health
Information Management System (HHIMS) developed by ICTA and the Ministry of Health is
implemented on most of these facilities. It is a comprehensive, integrated information management
system designed to manage health records/ information of hospitals.
In complementing the currently implemented HHIMS at these hospitals the implementation of a

Laboratory Information Management System (LIMS) will further improve the service offered to the
users of the hospital and increase the efficiency of the services offered and better utilization of the
limited facilities available. Currently at most of these hospitals availability of LIMS is limited and
only locally sourced ad-hoc LIMS solutions are to be found at some of these Apex Hospitals which
only connects some of the laboratory machines for basic networking.
The need to connect the Satellite Clinics / Collection Centers:
These Apex hospitals generally have satellite clinics with multiple lab sample collection centers
supporting the sample collection from patients of the surrounding localities. In order to serve the
population of these localities there is a plan to add more satellite clinics and laboratory sample
collection centers at various locations feeding the apex hospital in the future.
A robust and sustainable LIMS solution that can be applied to these Apex hospitals are an
immediate requirement, so that the laboratory equipment and the facilities available at these Apex
Hospital s could be efficiently and in the most beneficial manner.
Objectives:
The current Laboratory set up with a hospital generally consist of individual laboratory equipment
being utilised in isolation and most times on manual mode with all all information also being kept in
manual mode. Further these equipment are not utilised to their maximum potential and the overall
efficiency of the laboratories are low, requiring better efficiencies to improve the services offered to
the patients so that utilization of the limited facilities available is maximized. By being integrated
with the Hospital Health Information Management System (HHIMS) these software should deliver
significant value addition and efficiency improvements.
Expected Output:
As a Laboratory Information Management System (LIMS) is an essential part of a modern hospital

and laboratory set up, with more and more of the better run hospitals in the world moving to
implement these systems. A well designed and customized LIMS implemented at the Apex
Hospitals will improve efficiency, accuracy and the safety of the Laboratories at the facilities:
The following are some of the tangible benefits:
(i) Efficiency
 Generate & send reports
 Eliminate data loss and better analytical advantages due to the integration and digitization of the
data collected in the system
 Generate invoices and costing details including tracking the consumption, utilization of reagents,
consumables etc
 Rapid retrieval of data
 Access archived data
 Sample tracking including pre-analytical, analytical and post-analytical phase minimizes the risk
of sample getting lost
(ii) Accuracy
 Barcoding of each sample will facilitate maintaining the correct identity (chain-of-custody) as
well as tracking
 Bi-directional interfacing facilitates reduction in medical errors commonly happening because of
manual result entry
 Enhance quality control and overall quality of the results
 Verify data at input
 Avoid missed deadlines
 Elimination / Reduction in false results by features such as domain reference range which will
avoid medical errors of wrong results being published
(iii) Client Satisfaction and Security:
 Electronically notify customers including SMS notifications
 Helps to avoid unauthorized access to the critical clinical data
(iv) Productivity:
 Ability to track productivity and efficiency of the complete process
 Increase throughput
 Documentation of the laboratory output
 Effective utilization of time
Methodology:
The LIMS software will be installed at the laboratories of the Apex hospitals connecting the
compatible equipment via a dedicated network and the related IT infrastructure and the peripheral
sampling centers connected to the laboratories via the internet and work stations.
Application Deployment
The LIMS can be deployed on premise / on the cloud. The specific deployment architecture will be
decided based upon the High Availability and Disaster Recovery requirements of the hospitals.
Below is a typical deployment.
LIMS
Interphase Engine
Implementation Approach
Key features of project management strategy in implementing this system includes
 A staged project lifecycle, with each stage having defined objectives, tasks and deliverables
 Proactive issue, risk and resource management
 Continuous involvement of the right stake holders at the appropriate time during the
execution of the Implementation project.
 Maintaining open and transparent communication channels between the project sponsor,
project team and the rest of the organization
Implementation Project Process Flow
The project will begin with a Kick-off meeting with all the stakeholders of the project. The Project
Manager will prepare the Project Charter and the Project Plan in consultation with the stakeholders of
the MoH setting clear expectations. Based on the project plan the respective work streams will start
their activities.
The vendor’s project team will be required engage with the super users will and demonstrate each
function and gather user pain points and gaps if any. At the end of this exercise, based upon the
analysis of what pain points and gaps have been identified the application will need to be configured
to capture the issues. The vendor will be required to address the show stopper gaps in the product
before super user training. Further all nice to have gaps will be require documentation captured in
the product roadmap. The vendor will be required to publish the delivery schedule for the items in
the roadmap.
In the event of an Apex Hospital running a basic LIMS, the Implementation team will be required to
study the existing data and prepare for data migration.
For green field Apex hospitals, this process will be replaced with setting up the data by working with
the respective stakeholders. Once the master data setup is complete, the super users will be trained on
various functions. The super users will in turn train the end users at a later point in time. The super
users gather sufficient knowledge about the application and start preparing the User Aacceptance
Test scripts. The UAT is executed and upon successful completion of UAT, end user training is
carried out by the super users with support from the vendor.
Once training is completed a parallel run will be initiated. During parallel run, a subset of
transactions executed in the current live system will also be executed in the LMIS system. At the end
of this exercise, the reports from the 2 systems will be compared. This will also give an opportunity
for the users to get hands on the system and clarify any questions on specific scenarios.
In parallel, the vendor’s interface will study the lab equipment, radiology modalities and other HL7
medical devices that needs to be integrated with LMIS and implement the interfaces.
Once all the above is completed successfully, the LMIS system will be ready to Go Live.
Expected Month of Completion:
The Implementation will take generally 3 - 4 months
Estimated Costs: The estimated cost for the implementation will be as follows:
LIMS License including the following Modules, Hardware and Network will be LKR 35 milion per
Apex Hospital
LIMS with Following Modules:
a. General Compliance
b. Sample testing and verification
c. Result reporting for Registration, Phlebotomy, Technician Result Validation, Pathologist Result
Approval, Report Dispatch, Inventory, Audit, MIS Reports
d. Patient Portal Consisting of
I. Patient Registration
II. Test booking
III. Sample barcoding
IV. Worksheet generation
V. Result entry
VI. Result review
VII. Result reporting through multiple channels
VIII. Email & SMS notifications
IT infrastructure consisting of Network for the Laboratory and internet connectivity of the satellite
collection centers, Computers, Tablet Computers, Printers, Bar Code Readers, Screens, Servers UPSs
are included in this cost.

Gap Assessment For Laboratory Development CMLS - SL (BOOK 1)

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Gap Assessment For Laboratory Development CMLS - SL (BOOK 1)

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State sector healthcare services of

Sri Lanka provide universal health

College of Medical Laboratory Science

Strengthening Medial Laboratory Service in Sri Lanka ........................................... 2

1.1 Background: ........................................................................................................ 2

1.2 Function of Medical Laboratories ........................................................................ 4

1.3 Objectives ........................................................................................................... 6

2.1. Laboratory Organization and Structure: ............................................................. 6

2.2 Human Resource ................................................................................................. 7

2.3 Point of Care Testing for NCD screening program ............................................... 9

2.4 Laboratory Information Management System (LIMS) ......................................... 9

2.5 Total Quality Management ............................................................................... 10

3.0 Special Remarks of Assessment ........................................................................... 10

3.1 Sri Lanka Accreditation Board (SLAB) ................................................................ 10

3.2 Training Needs .................................................................................................. 11

Quality Management in Primary Medical Care Units ............................................ 12

Selection of POCT devices for Primary Healthcare Strengthening Project ......... 15

Proposal for Developing LIMS .................................................................................. 18

Primary Secondary Tertiary

Level 2 Level 1 Base Base National Teaching Provincial District

Divisional Primary Medical

Figure 1: Hospital laboratory set up in Sri Lanka

1.2.1 Tertiary care Laboratories:

1.2.2 Secondary care laboratories:

1.2.3 Primary care laboratories:

It is expected to achieve following objectives in primary healthcare system strengthening project

2.1. Laboratory Organization and Structure:

2.2 Human Resource:

2.2.1 Medial Laboratory Scientists for Level 2 laboratories

Number of Medical Laboratory Scientist or Medical Laboratory Technologists required for

2.2.2 Divisional Medical Laboratory Technologists (24 officers)

2.2.3 Medical Laboratory Scientist for Quality Management

2.4 Laboratory Information Management System (LIMS)

3.0 Special Remarks of Assessment

3.1 Sri Lanka Accreditation Board (SLAB)

3.2 Training Needs

2. Post graduate study opportunities in specialties in laboratory science namely microbiology,

Mr. Ravi Kumudesh – Collage of Medical Laboratory Science, Sri Lanka

Quality Management in Primary Medical Care Units

Prepared by Level 2 Laboratory Development committee of primary health care strengthening

1. Simpler sample collection

1. Errors due to lack of expertise and insufficient quality control

Total Quality Management of POCT

The uses shall have

DDG (LS) / D (LS) / PDHSS

Nominated Consultant Chemical Pathologist / Consultant Haematologist

Medical Laboratory Scientist (Divisional Quality Manager)

Divisional Medical Laboratory Scientist or Medical Laboratory Technologist

Other Medical Laboratory Scientist or Medical Laboratory Technologists

Healthcare workers performing POCT

Steps in Implementation and ongoing performance

Selection of POCT devices for Primary Healthcare Strengthening Project

B. Considering Diabetic Screening recommended and easiest screening parameter is Fasting

1. Capillary fasting plasma glucose

Report of a World Health organization and International Diabetes Federation meeting

Proposal for Developing a

Design, Supply, Development, Implementation and Support for Laboratory

Background and Justification:

In complementing the currently implemented HHIMS at these hospitals the implementation of a

The need to connect the Satellite Clinics / Collection Centers:

As a Laboratory Information Management System (LIMS) is an essential part of a modern hospital

The following are some of the tangible benefits:

 Generate & send reports